OsteoArthritis and Therapy for Sleep (OATS)
1 de abril de 2020 actualizado por: Michael Vitiello, University of Washington
Efficacy of Scalable CBT for Insomnia in Older Adults With Osteoarthritis Pain
Osteoarthritis (OA) pain affects 50 percent of older adults, more than half of whom also experience significant sleep disturbance.
This randomized trial will determine whether a telephone-based cognitive behavioral treatment targeting insomnia in older adults with chronic severe OA-related insomnia and pain results in substantially greater reductions in insomnia severity and in related improvements in pain, fatigue, mood, quality of life and healthcare costs compared to telephone-delivered education (attention control) about insomnia.
The trial will test an intervention that if demonstrated to have long term efficacy is scalable and has the potential for wide-scale deployment in healthcare systems.
Descripción general del estudio
Estado
Desconocido
Condiciones
Intervención / Tratamiento
Descripción detallada
Twenty-five percent of older adults experience significant osteoarthritis (OA)-related comorbid sleep disturbance.
Insomnia is associated with substantial negative effects on function, mood, and medical resource utilization.
Cognitive behavioral therapy for insomnia (CBT-I) is evidence based and has been shown to be efficacious in populations with a variety of comorbid conditions including OA-related chronic pain.
However, in-person CBT interventions are unlikely to be widely deployable in healthcare systems.
Telephone delivery has the advantage of giving patients access to personalized, efficacious CBT-I interventions from home, increasing generalizability, and outreach to minority, rural, and other underserved populations.
Older (60+ yrs) primary care patients across Washington State will be screened for severe persistent OA-related insomnia and pain.
Two hundred and seventy patients will be randomized to either CBT-I or an education only attention control (EOC).
Each treatment will consist of six 20-30 minute telephone-based sessions over an eight week period.
Pre-treatment, post-treatment (2 months and 12 month) assessments will include measures of sleep, pain, fatigue, mood, and quality of life.
A cost effectiveness evaluation of the intervention will also be conducted.
The proposed research will determine if telephone CBT-I improves OA insomnia and associated outcomes in a state-wide primary care population of older adults, and inform policy decisions about widespread dissemination of telephone CBT-I in this and related patient populations.
Tipo de estudio
Intervencionista
Inscripción (Actual)
327
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
-
-
Washington
-
Seattle, Washington, Estados Unidos, 98101
- Kaiser Permanente Washington Research Institute
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
60 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Age 60+ with one or more health care visits for OA in the prior 3 years
- Score of ≥6 on 4-item ISI at first screening and ≥11 on full ISI at second screening
- Score of ≥9 on two items from the Brief Pain Inventory (BPI) asking about average pain intensity in the past 2 weeks (0-10 scale) and activity interference due to pain (0-10 scale) at first and second screening
Exclusion Criteria:
- Not continuously enrolled at Group Health Cooperative for at least one year
- Prior diagnosis of a primary sleep disorder: sleep apnea with an AHI/RDI score of 15+ or current use of a CPAP machine; periodic leg movement disorder; restless leg syndrome; sleep-wake cycle disturbance; or rapid eye movement behavior disorder
- Diagnosis in the medical record of: rheumatoid arthritis, terminal disease, being considered for major surgery, active chemotherapy or radiation for cancer, or inpatient treatment for congestive heart failure within the previous 6 months
- Diagnosis of dementia, use of acetylcholinesterase inhibitor and/or memantine for cognitive impairment, or cognitive impairment (>6 on the Short Orientation-Memory-Concentration Test)
- Hearing or speech impairment sufficient to preclude participation in a telephone intervention
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Cognitive Behavioral Therapy
Cognitive Behavioral Therapy for Insomnia is delivered by trained sleep therapists in six telephone sessions.
|
Six telephone sessions that last 20-30 minutes presenting cognitive behavioral therapy for insomnia.
Otros nombres:
|
|
Comparador activo: Education Control
Education Only Control is delivered by trained sleep therapists in six telephone sessions.
|
Six telephone sessions that last 20-30 minutes presenting sleep and osteoarthritis education.
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Insomnia Severity Index (ISI)
Periodo de tiempo: 12 months post baseline
|
A 7-item questionnaire that is a global measure of perceived insomnia severity.
Items use a 5-point scale for total scores of 0-28, with >15 considered moderate severity.
|
12 months post baseline
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Insomnia Severity Index (ISI)
Periodo de tiempo: 2 months post baseline
|
A 7-item questionnaire that is a global measure of perceived insomnia severity.Items use a 5-point scale for total scores of 0-28, with >15 considered moderate severity.
|
2 months post baseline
|
|
Pittsburgh Sleep Quality Index (PSQI)
Periodo de tiempo: 2 months post baseline
|
Self-rating of overall sleep quality and disturbances using 7 sleep.
components.
PSQI global >5 is highly sensitive and specific for distinguishing good and poor sleepers.
|
2 months post baseline
|
|
Pittsburgh Sleep Quality Index (PSQI)
Periodo de tiempo: 12 months post baseline
|
Self-rating of overall sleep quality and disturbances using 7 sleep components.
PSQI global >5 is highly sensitive and specific for distinguishing good and poor sleepers.
|
12 months post baseline
|
|
Brief Pain Inventory-short form (BPI-sf)
Periodo de tiempo: 2 months post baseline
|
A questionnaire to assess pain intensity and interference with activities.
The BPI-sf rates pain intensity (4 items) and interference (7 items) from 0 to 10 and is validated for use in clinical trials with OA pain patients.
|
2 months post baseline
|
|
Brief Pain Inventory-short form (BPI-sf)
Periodo de tiempo: 12 months post baseline
|
A questionnaire to assess pain intensity and interference with activities.
The BPI-sf rates pain intensity (4 items) and interference (7 items) from 0 to 10 and is validated for use in clinical trials with OA pain patients.
|
12 months post baseline
|
|
Flinders Fatigue Scale (FFS)
Periodo de tiempo: 2 months post baseline
|
A 7-item self-report questionnaire to measure fatigue level in a variety of situations.
|
2 months post baseline
|
|
Flinders Fatigue Scale (FFS)
Periodo de tiempo: 12 months post baseline
|
A 7-item self-report questionnaire to measure fatigue level in a variety of situations.
|
12 months post baseline
|
|
Patient Health Questionnaire (PHQ-8)
Periodo de tiempo: 2 months post baseline
|
4-point scale rates frequency of occurrence of 8 depressive symptoms.
|
2 months post baseline
|
|
Patient Health Questionnaire (PHQ-8)
Periodo de tiempo: 12 months post baseline
|
4-point scale rates frequency of occurrence of 8 depressive symptoms.
|
12 months post baseline
|
|
Sleep Hygiene Index (SHI)
Periodo de tiempo: 2 months post baseline
|
A 13-item scale that rates how often participants engage in specific sleep hygiene related behaviors, including continued adherence to CBT-I recommendations over time.
|
2 months post baseline
|
|
Sleep Hygiene Index (SHI)
Periodo de tiempo: 12 months post baseline
|
A 13-item scale that rates how often participants engage in specific sleep hygiene related behaviors, including continued adherence to CBT-I recommendations over time.
|
12 months post baseline
|
|
EuroQoL 5D (EQ-5D)
Periodo de tiempo: 2 months post baseline
|
Rates health status on five dimensions and overall health status from 0 to 100.
The most widely used measure in clinical trials assessing general quality of life of OA patients.
|
2 months post baseline
|
|
EuroQoL 5D (EQ-5D)
Periodo de tiempo: 12 months post baseline
|
Rates health status on five dimensions and overall health status from 0 to 100.
The most widely used measure in clinical trials assessing general quality of life of OA patients.
|
12 months post baseline
|
|
Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Periodo de tiempo: 2 months post baseline
|
A 24-item questionnaire rating pain, stiffness, and physical functioning in everyday activities.
It is the most widely used condition-specific quality of life measure for arthritis cost-effectiveness studies.
|
2 months post baseline
|
|
Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Periodo de tiempo: 12 months post baseline
|
A 24-item questionnaire rating pain, stiffness, and physical functioning in everyday activities.
It is the most widely used condition-specific quality of life measure for arthritis cost-effectiveness studies.
|
12 months post baseline
|
|
Use of sleep and pain medications
Periodo de tiempo: Baseline through 24 months
|
NSAID, analgesic, sedative, and anti-depressant medication use.
|
Baseline through 24 months
|
|
Outpatient visits
Periodo de tiempo: Baseline through 24 months
|
The number of visits for OA, for sleep problems, and for visits irrespective of associated diagnosis.
|
Baseline through 24 months
|
|
Health care costs
Periodo de tiempo: Baseline through 24 months
|
The Group Health cost database will be used to estimate costs (from study entry to 24 months post enrollment) of ambulatory healthcare for all conditions, arthritis and sleep problems, and inpatient care.
|
Baseline through 24 months
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Michael V Vitiello, PhD, University of Washington
- Investigador principal: Michael Von Korff, ScD, University of Washington
- Investigador principal: Kai Yeung, PhD, Kaiser Permanente
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Thakral M, Von Korff M, McCurry SM, Morin CM, Vitiello MV. ISI-3: evaluation of a brief screening tool for insomnia. Sleep Med. 2021 Jun;82:104-109. doi: 10.1016/j.sleep.2020.08.027. Epub 2020 Aug 27.
- Vitiello MV, Zhu W, Von Korff M, Wellman R, Morin CM, Yeung K, McCurry SM. Long-term improvements in sleep, pain, depression, and fatigue in older adults with comorbid osteoarthritis pain and insomnia. Sleep. 2022 Feb 14;45(2):zsab231. doi: 10.1093/sleep/zsab231.
- McCurry SM, Zhu W, Von Korff M, Wellman R, Morin CM, Thakral M, Yeung K, Vitiello MV. Effect of Telephone Cognitive Behavioral Therapy for Insomnia in Older Adults With Osteoarthritis Pain: A Randomized Clinical Trial. JAMA Intern Med. 2021 Apr 1;181(4):530-538. doi: 10.1001/jamainternmed.2020.9049.
- McCurry SM, Von Korff M, Morin CM, Cunningham A, Pike KC, Thakral M, Wellman R, Yeung K, Zhu W, Vitiello MV. Telephone interventions for co-morbid insomnia and osteoarthritis pain: The OsteoArthritis and Therapy for Sleep (OATS) randomized trial design. Contemp Clin Trials. 2019 Dec;87:105851. doi: 10.1016/j.cct.2019.105851. Epub 2019 Oct 13.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de octubre de 2016
Finalización primaria (Actual)
1 de diciembre de 2019
Finalización del estudio (Anticipado)
1 de noviembre de 2020
Fechas de registro del estudio
Enviado por primera vez
19 de octubre de 2016
Primero enviado que cumplió con los criterios de control de calidad
25 de octubre de 2016
Publicado por primera vez (Estimar)
27 de octubre de 2016
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
3 de abril de 2020
Última actualización enviada que cumplió con los criterios de control de calidad
1 de abril de 2020
Última verificación
1 de marzo de 2020
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 52176
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre Cognitive Behavior Therapy for Insomnia
-
Boston Children's HospitalTerminadoEstrés Psicológico | Problema de aculturaciónEstados Unidos